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Completed

NCT Number: NCT07048847

The Effect of Aerobic Exercise on Selective Biomarkers of Patients With Cancer

This study is a single-blinded, prospective, controlled trial aiming to evaluate the effect of supervised aerobic exercise on adipokine and myokine biomarkers in patients with breast or colon cancer during their systemic chemotherapy.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Chemotherapy Effect Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bakircay University Çiğli State and Training Hospital, Department of Medical Oncology

Izmir, Çiğli, 35620, Turkey (Türkiye)

About this study

To determine the effect of aerobic exercise on adipokine and myokine biomarkers such as Interleukin-6 (IL-6), Irisin, Leptin and Adiponectin in the blood of breast or colon cancer patients receiving chemotherapy compared to ones who did not exercise during their systemic chemotherapy.

Patients who were diagnosed with solid type of cancer specifically focusing on breast or colon cancer will be recruited either to the exercise group (EG) or control group (CG) during their systemic chemotherapy. An individualized supervised resistive aerobic exercise which will be performed via stationary resistive biycle ergometer will be implemented along with the chemotherapy process for EG.

Each exercise session will be performed 2 times per week for at least 12 weeks (can be extended up to 24 weeks) during chemotherapy.

Exercise intensity will be set as submaximal, 50-70% of heart rate reserve, and each session will be lasted 35 minutes.

All exercise sessions will be supervised by the researchers to avoid potential side effects.

5 cc venous blood samples will be collected before the first and last chemotherapy infusions (for both EG and CG). The samples will be blinded to the analyzers did not know which group the samples belonged to.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having been diagnosed with solid type of cancer
  • Being candidate for systemic chemotherapy
  • Being volunteer to participate in an exercise program
  • Aged between 18-70 years old

Exclusion criteria

  • Having 2 or above grades according to the Eastern Cooperative Oncology Group (ECOG) performance status
  • Having mental and/or cognitive deficits
  • Ongoing medical and/or surgical (if any) complications
  • Having neurological/orthopedical and/or severe respiratory dysfunctions
  • Having any condition which corresponds to the contraindication of exercise (i.e. advanced stages, distant metastasis, infection)
  • Having unstable vital parameters or having regularly used pharmacological interventions

Treatment and study plan

Exercise

Other

The exercise program will be started with 25 Watt (W) for 5 minutes of warm-up. Then it is steadily increased automatically by 5W in 5 minutes apart for 25 minutes for the loading period. The last 5 minutes which will be started by lowering the load to 25 W for cooling will be implemented for cooling down. To prevent acommodation, the warm-up period will be modified by increasing nearly 10% of its previous rate three weeks apart.A submaximal exercise prescription will be followed according to the American College of Sports Medicine guideline by taking into attention 50-70% of Heart Rate Reserve.A submaximal exercise prescription will be followed according to the American College of Sports Medicine guideline by taking into attention 50-70% of Heart Rate Reserve.

Other names: Control

Primary outcomes

  1. Irisin

    Time frame: Baseline

    Measuring Serum levels of Irisin via ELISA

  2. Irisin

    Time frame: From completion of systemic chemotherapy up to one week

    Measuring Serum levels of Irisin via ELISA

  3. Leptin

    Time frame: Baseline

    Measuring Serum levels of Leptin via ELISA

  4. Leptin

    Time frame: From completion of systemic chemotherapy up to one week

    Measuring Serum levels of Leptin via ELISA

  5. Adiponectin

    Time frame: Baseline

    Measuring Serum levels of Adiponectin via ELISA

  6. Adiponectin

    Time frame: From completion of systemic chemotherapy up to one week

    Measuring Serum levels of Adiponectin via ELISA

  7. Interleukin-6 (IL-6)

    Time frame: Baseline

    Measuring Serum levels of IL-6 via ELISA

  8. Interleukin-6 (IL-6)

    Time frame: From completion of systemic chemotherapy up to one week

    Measuring Serum levels of IL-6 via ELISA

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study title

The Effect of Supervised Aerobic Exercise on Adipokine and Myokine Biomarkers in Patients With Cancer During Systemic Chemotherapy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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